The Effect of Consumption of Almonds and Snack Mix Daily for 6 Months on Cognitive Function in Older Adults

NCT ID: NCT03093896

Last Updated: 2020-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-05-31

Brief Summary

Cognitive impairment is also a major risk factor for development of dementia later in life. Findings from recent studies suggest that the there are many nutrients contained in foods that may be important in cognitive function in the elderly. This study evaluates long-term intervention with almonds and snack mix as a treatment strategy for age-related cognitive impairment which could possibly prevent the onset of dementia.

The proposed study is designed as a randomized, placebo controlled trial that tests the effects of 6 month supplementation with 1.5 or 3 ounces of almonds or 3 ounces of shortbread containing coconut oil on cognitive function in older adults. Secondary outcomes include plasma biomarkers of oxidative stress and inflammation.

Detailed Description

The study is designed as a controlled trial that tests the effects of 6 month supplementation with 1.5 or 3 ounces of almonds or 3 ounces of snack mix a day on cognitive function in older adults. Subjects will be randomly assigned to one of the three groups. Secondary outcomes include plasma biomarkers of oxidative stress and inflammation. Participants will be recruited from community-dwelling men and women aged greater than of equal to 50 yr and less than or equal to 75 years and potential participants will be screened to meet cognitive and functional criteria. Participants will be pre-screened by telephone; those who appear to meet criteria will undergo further screening.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

snack mix

snack mix, 3 ounces: dried coconut, meat jerky, butter, cereal party mix

Group Type: PLACEBO_COMPARATOR

snack mix

Intervention Type: DIETARY_SUPPLEMENT

commercial cereal mix with bits of beef jerky and coconut

almonds, 1.5 ounces

almonds, 1.5 ounces/day

Group Type: ACTIVE_COMPARATOR

almonds, 1.5 oz

Intervention Type: DIETARY_SUPPLEMENT

almonds, 1.5 oz/day

almonds, 3 ounces

almonds, 3 ounces/day

Group Type: ACTIVE_COMPARATOR

almonds, 3 oz

Intervention Type: DIETARY_SUPPLEMENT

almonds, 3.0 oz/day

Interventions

snack mix

commercial cereal mix with bits of beef jerky and coconut

Intervention Type: DIETARY_SUPPLEMENT

almonds, 1.5 oz

almonds, 1.5 oz/day

Intervention Type: DIETARY_SUPPLEMENT

almonds, 3 oz

almonds, 3.0 oz/day

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

almonds, 3.0 oz

Eligibility Criteria

Inclusion Criteria

• men and women age >50 - 75 years
• body mass index >25-35 kg/m2
• Mini mental state exam (MMSE) score >24
• must be able to give written informed consent

Exclusion Criteria

• history of active small bowel disease or resection
• atrophic gastritis
• uncontrolled blood pressure or untreated hypertension alcoholism (>2 drinks/d or 14 drinks/week)
• abnormal hematologic parameters that are determined by the study MD to influence study outcomes.
• endocrine disorders including diabetes or current pharmacological treatment of diabetes and untreated thyroid disease
• pancreatic disease
• anemia, and bleeding disorders
• nut allergy
• major chronic illness that might interfere with the study outcomes
• active cancer except for prostate cancer or cancer-free for at least 5 years
• unwilling to not use lutein, n3 fatty acid, or choline supplements for 2 months prior to study start
• diseases that interfere with fat absorption, e.g. colitis, celiac disease, Crohn's disease, cystic fibrosis (as determined by screening interview)
• rheumatologic diseases including gout or inflammatory arthritis
• immune deficiency conditions including autoimmune dieases, human immune deficiency virus (HIV); history of organ transplantation
• medications that interfere with fat absorption, e.g. bile sequestrants (as determined by screening interview)
• use of antipsychotic, antimanic, anti-inflammatory (except for aspirin and non steroidal anti-inflammatory drugs[NSAIDS]), monoamine inhibitors, or dementia medications
• inability to discontinue aspirin, NSAIDS for 72 hours prior to and for the duration of testing at study visits (baseline, 3 and 6 months)
• daily intake of proton pump inhibitors or H2 blockers
• smoking or use of nicotine patches or gum (within past 6 months)
• use of drugs suspected of interfering with metabolism of blood clotting with the exception of aspirin and NSAIDS, e.g. warfarin (as determined by screening interview)
• stroke, head injury with loss of consciousness or seizures.
• history or clinical manifestation of any significant neurologic disorder in the opinion of the investigator.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Johnson

Scientist I/Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth J Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts University

Locations

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, United States

Countries

United States

References

Mustra Rakic J, Tanprasertsuk J, Scott TM, Rasmussen HM, Mohn ES, Chen CO, Johnson EJ. Effects of daily almond consumption for six months on cognitive measures in healthy middle-aged to older adults: a randomized control trial. Nutr Neurosci. 2022 Jul;25(7):1466-1476. doi: 10.1080/1028415X.2020.1868805. Epub 2021 Jan 15.

Reference Type: DERIVED

PMID: 33448906 (View on PubMed)

Other Identifiers

003

Identifier Type: -

Identifier Source: org_study_id